The device was designed for the assessment of diabetic retinopathy during routine visits, the manufacturer explained on its website, but should not be viewed as a replacement for routine eye examinations at ages 40 and 60, according to the FDA news release. "The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care".
The device and software can be used by health care providers who don't normally provide eye care services. The physician uploads the patient's retinal images to a cloud server where the IDx-DR software is installed. The software tells the doctor that the patient either has more than mild diabetic retinopathy and should be referred to eye care professional for possible treatment, or is "negative" for more than mild diabetic retinopathy and should be rescreened in 12 months.
IDx-DR was evaluated in a clinical study involving retinal images from 900 patients with diabetes to determine how often IDx-DR could accurately detect patients with greater than mild diabetic retinopathy.
The IDx-DR is made to detect the most common cause of vision loss among more than 30 million Americans living with diabetes. It also ruled out more-than-mild diabetic retinopathy 89.5% of the time.
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The FDA, however, said that IDx-DR should not be used in patients with diabetes who are pregnant as diabetic retinopathy can progress very rapidly during pregnancy and the device is not meant to evaluate rapidly progressive diabetic retinopathy.
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The FDA reviewed IDx-DR under its De Novo premarket review pathway, which is targeted toward "novel" low- to moderate-risk medical devices, the FDA noted in an April 11 statement. It was developed by privately held IDx LLC.